None listed
Conditions
Brief summary
Differentiation between bilateral and unilateral (aldosterone-producing adenoma, APA) causes of primary aldosteronism (PA) relies on CT imaging of the adrenal glands and adrenal vein sampling (AVS), the latter of which is the current gold standard. CT imaging is limited by a high rate of adrenal incidentalomas, which can lead to dilemmas in management and pursuance of extensive investigations. AVS is operator dependent, labour intensive, expensive and invasive, also posing the risk of a failed or inconclusive study. We conduct this pilot prospective study in adults with confirmed PA with the objective of evaluating the efficacy of 68Ga-PentixaFor PET-CT in determining if an adrenal adenoma is the cause for primary aldosteronism, compared to AVS as the gold standard.
Interventions
The intended intervention in this trial is a 68Ga-PentixaFor PET-CT scan, performed in individuals with confirmed primary aldosteronism and an adrenal adenoma, who are planned to undergo adrenal vein sampling (AVS) for subtyping. This nuclear medicine study will be timed to occur within 2-4 weeks of AVS. All participants will undergo both AVS and the PET-CT scan, with the result of the latter being compared to AVS which is the current gold standard for subtyping primary aldosteronism.
There wil
The intended intervention in this trial is a 68Ga-PentixaFor PET-CT scan, performed in individuals with confirmed primary aldosteronism and an adrenal adenoma, who are planned to undergo adrenal vein sampling (AVS) for subtyping. This nuclear medicine study will be timed to occur within 2-4 weeks of AVS. All participants will undergo both AVS and the PET-CT scan, with the result of the latter being compared to AVS which is the current gold standard for subtyping primary aldosteronism. There will be no pre-treatment preceding the scan. The nuclear medicine procedure will require intravenous administration of the tracer, followed by dynamic PET/CT imaging at 10 and 40 mins. The dose of intravenously injected [68Ga]Ga-PentixaFor PET/CT will be calculated based on the patient's weight (1.85 MBq [0.05mCi]/kg). PET/CT scanning will be performed at 10 minutes and 40 minutes after the injection of the intravenous tracer. The PET/CT image will be evaluated by an experienced nuclear medicine physician who is blinded to the AVS result. The shape and density of adrenal glands will be analyzed. The 68Ga-PET/CT intervention will be administered by a nuclear medicine physician and on-site technician. Scans will be made from the vertex to upper thighs, with an acquisition time equivalent to 3-5 minutes per step. The complete procedure for the scan will require one visit to the nuclear medicine department. AVS occurring as part of standard care will be performed by one of two skilled interventional radiologists who routinely perform this procedure for our centre.
Sponsors
Monash Health - Department of Endocrinology
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Age > 18 2) Confirmed diagnosis of primary aldosteronism 3) Adrenal adenoma seen on CT (any size, either unilateral or bilateral) 4) Planned for lateralisation with AVS (consented for and suitable to undergo AVS)
Exclusion criteria
1) Pregnancy or breastfeeding 2) Current active malignancy 3) Cortisol excess – morning cortisol > 50 nmol/L after 1mg dexamethasone suppression test 4) Familial hyperaldosteronism 5) Imaging suggestive of phaeochromocytoma or adrenal cortical carcinoma 6) Unable to come off interfering medications (e.g. due to severe hypertension)
Outcome results
None listed